Appendix
IV: Clinical trial compensation guidelines
Clinical
Trial Compensation Guidelines |
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Preamble
The Clinical Trials Committee of the South African Medicines
Control Council has adopted the following guidelines on clinical
trial compensation. These Guidelines are based on those of the
Association of the British Pharmaceutical Industry.10
Introduction
The
Association of the British Pharmaceutical Industry favours a
simple and expeditious procedure in relation to the provision
of compensation for injury caused by a participation in clinical
trials. The Association therefore recommends that a member company
sponsoring a clinical trial should provide without legal commitment
a written assurance to the investigator - and through him/her
to the relevant Research Ethics Committee - that the following
Guidelines will be adhered to in the event of injury caused
to a patient attributable to participation in the trial question.
1.
Basic principles
| 1.1 |
Notwithstanding
the absence of legal commitment, the company should pay
compensation to patient-volunteers suffering bodily injury
(including death) in accordance with these Guidelines. |
| 1.2 |
Compensation
should be paid when, on the balance of probabilities, the
injury was attributable to the administration of a medicinal
product under trial or any clinical intervention or procedure
provided for by the protocol that would not have occurred
but for the inclusion of the patient in the trial. |
| 1.3 |
Compensation
should be paid to a child injured in utero through the participation
of the subject's mother in a clinical trial as if the child
were patient-volunteer with the full benefits of these Guidelines.
|
| 1.4 |
Compensation
should only be paid for the more serious injury of an enduring
and disabling character (including exacerbation of an existing
condition) and not for temporary pain or discomfort or less
serious or curable complaints. |
| 1.5 |
Where
there is an adverse reaction to a medicinal product under
trial and injury is caused by a procedure adopted to deal
with that adverse reaction, compensation should be paid
for such injury as if it were caused directly by the medicinal
product under trial. |
| 1.6 |
Neither
the fact that the adverse reaction causing the injury was
foreseeable or predictable, nor the fact that the patient
has freely consented (whether in writing or otherwise) to
participate in the trial should exclude patient from consideration
for compensation under these Guidelines, although compensation
may be abated or excluded in the light of the factors described
in paragraph 4.2 below. |
| 1.7 |
For
the avoidance of doubt, compensation should be paid regardless
of whether the patient is able to prove that the company
has been negligent in relation to research or development
of the medicinal product under trial or that the project
is defective and therefore, as the producer, the company
is subject to strict liability in respect of injuries caused
by it. |
2.
Type of clinical research covered
| 2.1 |
These
Guidelines apply to injury caused to patients involved in
Phase II and Phase III trials, that is to say, patients
under treatment and surveillance (usually in hospital) and
suffering from the ailment which the medicinal product under
trial is intended but for which a product licence does not
exist or does not authorise supply for administration under
the conditions of the trial. |
| 2.2 |
These
Guidelines do not apply to injuries arising from studies
in non-patient volunteers (Phase I), whether or not they
are in hospital, for which separate Guidelines for compensation
already exist.1 |
| 2.3 |
These
guidelines do not apply to injury arising from clinical
trials on marketed products (Phase IV) where a product licence
exists authorising supply for administration under the conditions
of the trial, except to the extent that the injury is caused
to a patient as a direct result of procedures undertaken
in accordance with the protocol (but not any product administered)
to which the patient would not have been exposed had treatment
been other than in the course of the trial. |
| 2.4 |
These
guidelines do not apply to clinical trials, which have not
been initiated or directly sponsored by the company providing
the product for research. When trials of products are initiated
independently by doctors under the appropriate Medicines
Act 1968 exemptions, responsibility for the health and welfare
of patients rests with the doctor alone (see also paragraph
5.2 below). |
3.
Limitations
| 3.1 |
No
compensation should be paid for the failure of the medicinal
product to have its intended effect or to provide any other
benefit to the patient. |
| 3.2 |
No
compensation should be paid for injury caused by other licensed
medicinal products administered to the patient for the purpose
of comparison with the product under trial. |
| 3.3 |
No
compensation should be paid to patients receiving placebo
in consideration of its failure to provide a therapeutic
benefit. |
| 3.4 |
No
compensation should be paid (or should be abated as the
case may be) to the extent that the injury has arisen:
| 3.4.1 |
through
a significant departure from the agreed protocol; |
| 3.4.2 |
through
the wrongful act or default of a third party, including
a doctor's failure to deal adequately with an adverse
reaction; or |
| 3.4.3 |
through
contributory negligence by the patient. |
|
4.
Assessment of compensation
| 4.1 |
The
amount of compensation paid should be appropriate to the
nature, severity and persistence of the injury and should
in general terms be consistent with the quantum of damages
commonly awarded for similar injuries by Court of law in
cases where legal liability is admitted. |
| 4.2 |
Compensation
may be debated, when certain circumstances excluded, in
the light of the following factors (on which will depend
the level of risk the patient can reasonably be expected
to accept):
| 4.2.1 |
the
seriousness of the disease being treated, the degree
of probability that adverse reactions will occur and
any warnings given; or |
| 4.2.2 |
the
risks and benefits of established treatments relative
to those known or suspected of the trial medicine.
This
reflects the fact that flexibility is required given
the particular patient's circumstances. As an extreme
example, there may be a patient suffering from a
serious or life-threatening disease who is warned
of a certain defined risk of an adverse reaction.
Participation in the trial is then based on an expectation
that the benefit/risk ratio associated with participation
may be better than that associated with alternative
treatment. It is, therefore, reasonable that the
patient accepts the high-risk and should not expect
compensation for the occurrence of the adverse reaction
of which he or she was told. |
|
| 4.3 |
In
any case where the company concedes that a payment should
be made to a patient but there exists the difference of
opinion between company and patient as to the appropriate
level of compensation, it is recommended that the company
agrees to seek at its own costs (and make available to the
patient) the opinion of a mutually acceptable independent
expert, and that his opinion should be given substantial
weight by the company in reaching its decision on the appropriate
payment to be made. |
5.
Miscellaneous
| 5.1 |
Claims
pursuant to the Guidelines should be made by the patient
to the company, preferably via the investigator, seeking
out details of the nature and background of the claim and,
subject to the patient providing on request an authority
for the company to review any medical records relevant to
the claim, the company should consider the claim expeditiously. |
| 5.2 |
The
undertaking given by a company extends to injury arising
(at whatever time) from all administrations, clinical interventions
or procedures occurring during the course of the trial but
not to treatment extended beyond the end of the trial at
the instigation of the investigator. The use of unlicenced
products beyond the trial period is wholly the responsibility
of the treating doctor and in this regard attention is drawn
to the advice provided to doctors in MAL 302 concerning
the desirability of doctors notifying their protection society
of the use of unlicenced products. |
| 5.3 |
The
fact that company has agreed to abide by these Guidelines
in respect of a trial does not affect the right of a patient
to pursue a legal remedy in respect of injury alleged to
have been suffered as a result of participation. Nonetheless,
patients will normally be asked to accept that any payment
made under the Guidelines will be in full settlement of
their claims. |
| 5.4 |
A
company sponsoring a trial should encourage the investigator
to make clear to participating patients that the trial is
being conducted subject to the ABPI guidelines relating
to compensation for injury arising in the course of clinical
trials and have available copies of the Guidelines should
they be requested. |
| 5.5 |
Where
studies are carried out in a hospital, the hospital continues
to have a duty of care to the patient being treated within
that hospital, whether or not the patient is participating
in an MRC-supported study. Therefore the MRC does not accept
liability for negligence on the part of employees of, or
staff engaged by, hospitals. This applies whether the hospital
is private or public sector. The MRC cannot be held liable
for any breach in the hospital's duty of care. |
6.
References
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Guidelines for medical experiments in non-patient human volunteers,
ABPI March 1988, as amended May 1990.
-
MAL30 A guide to the provisions affecting doctors and dentists,
DHSS, revised June 1985.
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